MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120PA; TRANSMITTER

Model Number	GZ-120PA
Medical Device Problem Codes	Power Problem (3010); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer reported that the gz telemeter's battery contact was broken, causing the telemeter to lose power intermittently.
Additional Manufacturer Narrative
The biomedical engineer reported that the gz telemeter's battery contact was broken, causing the telemeter to lose power intermittently.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
Event or Problem Description
The biomedical engineer (bme) reported that the gz telemeter's battery contact was broken, causing it to intermittently lose power.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the gz telemeter's battery contact was broken, causing it to intermittently lose power.No patient harm or injury was reported.Investigation summary: the device was also missing the battery cover.Damaged battery contacts are the result of forcibly inserting batteries as stated in the hazard document (b)(4).The actions taken in designs are: device is equipped with a torsion spring to minimize terminal damage / deformation, device is equipped with over current protection in case battery is inserted incorrectly, design of the battery compartment in which the battery cannot be inserted in the opposite polarity, attached a sign that indicates the direction of batteries.The actions taken in labelling include: shows a figure of how to insert the batteries.The battery cover is securely attached to the gz transmitter via a flexible strap.The cause of the damage could not be determined.Given the damage reported on the battery contacts, it is presumed that the device was handled roughly.The service history for this gz device shows this is an isolated incident with no recurrence history for this device.

• Brand Name: GZ-120PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11516404
• Report Number: 8030229-2021-00157
• Device Sequence Number: 14310393
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GZ-120PA
• Device Catalogue Number: GZ-120PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CENTRAL NURSING STATION (CNS); CENTRAL NURSING STATION (CNS)
• Patient Sex: Unknown